NCT06697379

Brief Summary

Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

2.9 years

First QC Date

November 5, 2024

Last Update Submit

November 18, 2024

Conditions

Biosafety ProtectionInfectious Diseases

Outcome Measures

Primary Outcomes (1)

  • Performance evaluation of medical protective clothing

    Evaluate the performance of self-developed equipment versus commercially developed equipment, such as protective clothing, hoods, boots and gloves. Protective clothing: Surface moisture resistance: according to the standard including GB/T 4745-1997 on the level of water, the protective clothing outside the water level is not less than level 3 Hydrostatic pressure: according to GB/T 4744-1997, the hydrostatic pressure is not less than 1.67kPa or 17cmH2O. Moisture permeability: according to GB/T 12704-1991, the moisture permeability is not less than 2500g/(m²-24h). Water staining test: according to GB/T 4745-1997, the outer water staining level is not less than 3. Microbiological barrier performance: the protective clothing should meet the requirements of microbiological indicators in GB 15979-2002 to ensure that it can effectively block the invasion of bacteria, viruses and other microorganisms.

    3 years

Secondary Outcomes (1)

  • Protective headgear performance evaluation

    3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

You may qualify if:

  • Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital medical university

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor, Professor

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 20, 2024

Study Start

January 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Locations

CN(1)